FDA 510(k), K031831, TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
FDA 510(k), K031831, TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
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510(K) Number: K031831
Device Name: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Manufacturer: DONALD H WINFIELD
Device Classification Name: Refractometer, Ophthalmic
Regulation Number: HKO
Classification Product Code: 06/13/2003
Date Received: 12/19/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Manufacturer: DONALD H WINFIELD
Device Classification Name: Refractometer, Ophthalmic
Regulation Number: HKO
Classification Product Code: 06/13/2003
Date Received: 12/19/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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